Danish Pharmacovigilance Update, February 2015

16 March 2015

The February issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news:

News from the EU

  • EMA tightens guidelines for use of hydroxyzine-containing medicines (Atarax®, etc.) to minimise the risk of heart rhythm disturbances, page 2
  • EU's list of recommendations on safety signals, page 3

News from the DHMA

  • Be aware of the risk of pulmonary fibrosis in long-term treatment with nitrofurantoin (Nitrofurantoin DAK) – new review and analysis by DHMA, page 4
  • The number of melatonin users under 25 years of age keeps increasing, page 5
  • DHMA keeps watch on isotretinoin for acne treatment, page 5
  • DHMA has focus on ADHD medicines and cardiovascular disturbances, page 6
  • Tramadol (Mandolgin®, etc.) and convulsions, page 7
  • Pay attention to patient's renal function before and during treatment with the non-vitamin K antagonists Pradaxa®, Eliquis and Xarelto®, page 8

Short news

  • Most recent Direct Healthcare Professional Communications (DHPCs), page 1


Danish Pharmacovigilance Update February 2015